FDA WARNING_LETTER - Golden Medal Mushroom Inc. - May 18, 2021

On October 21, 2021, the FDA issued a Warning Letter to Golden Medal Mushroom Inc. following a Foreign Supplier Verification Programs (FSVP) inspection conducted on May 12-13 and May 18, 2021. The inspection was prompted by the Michigan Department of Agriculture and Rural Development (MDARD) finding *Listeria monocytogenes* in enoki mushrooms distributed by the firm, imported from foreign supplier (b)(4). This led to a Class I recall on April 22, 2021, and the placement of (b)(4)'s enoki mushrooms on Import Alert #99-23.

The inspection revealed significant violations of the FSVP regulation (21 CFR part 1, subpart L), specifically that Golden Medal Mushroom Inc. did not develop, maintain, or follow an FSVP for any imported foods, including the enoki mushrooms from (b)(4), violating section 805 of the FD&C Act. The firm's May 22, 2021, response, stating an intent to develop an FSVP within six months, was deemed inadequate due to a lack of detailed implementation plans or documentation.

Furthermore, the firm failed to take appropriate corrective actions as required by 21 CFR 1.508(a) after being notified of *L. monocytogenes* contamination. Despite the initial recall, Golden